GCP Compliance

GCP Compliance at Dr. Oestreich + Partner GmbH

The first principle for GCP (Good Clinical Practice) compliance stresses, "to ensure good clinical practice in the planning, implementation, documentation and reporting of clinical trials in humans." As a full-service Clinical Research Institute operational since 1991, GCP compliance, in the form of standard operating procedures (SOPs), is firmly anchored in all work steps and subsequent decision making processes.

Our employees have gained their expert qualifications through year-long experience in hospitals, academic institutions and international research and development companies. They support and advise our customers drawing on highly qualified know-how with respect to GCP compliance. At the same time we closely track the course of the project with the interests of our customers uppermost and we weigh up the costs and benefits at each stage of project planning.

Within the framework of GCP compliance and on behalf of our clients, we carry out all correspondence with authorities and ethics committees, including the creation of protocols and case report forms (CRFs) or electronic CRFs (eCRFs) and involve all decision-makers at a sufficiently early stage. To ensure a success-oriented and efficient study conduct in terms of GCP compliance, we instruct all project staff on the project workflow and define their individual responsibilities at the beginning of a clinical trial.

GCP Compliance - Data Protection

By employing various content management and documentation systems (for example, electronic data capture - EDC), we are able to perform a streamlined patient-selection that facilitates a timely and objectives-oriented study start. At the same time, we also provide you with comprehensive sources of information through our online data bases OPVERDI and PMSBOX. All project data may be accessed at any time by authorized personnel who access the data in real time. The data include the electronic results of specific investigations, which are transferred into the data base from other sources in a secure manner. Similarly, our databases and content management systems conform to data protection requirements to ensure the privacy of patient data in terms of both legal requirements and GCP compliance.

Further information on clinical research and GCP compliance can be found here:

http://www.oandp-cro.com/quality-assurance/


EMA Pharmacovigilance
Health care studies
Observational studies
EMA Pharmacovigilance
Medical Biometrics
Approval of Medical Devices
Pharmacovigilance
Clinical Investigators
Clinical Trials
GCP Legislation
GCP - Good Clinical Practice
ICH GCP E6
GCP Guidelines
GCP Compliance
BfArM GCP
Clinical Research Organisation
Contract Research Organisation
PSUR
PSURs
Pharmacoeconomics, Health
Pharmacoeconomic studies
Pharmacoeconomics
Patient Monitoring
Monitoring Clinical Trials
Clinical Monitor
Marketing Authorisation
Medicinal Product Approval
Drug safety
Data management plan
Clinical development
Monitoring investigators
Non-interventional studies (NIS)
Patient recruitment
Phase IV studies
Investigator audit
Investigator qualification
Investigator selection

EMA Pharmacovigilance · Health care studies · Observational studies · EMA Pharmacovigilance · Medical Biometrics · Approval of Medical Devices · Pharmacovigilance · Clinical Investigators · Clinical Trials · GCP Legislation · GCP - Good Clinical Practice · ICH GCP E6 · GCP Guidelines · GCP Compliance · BfArM GCP · Clinical Research Organisation · Contract Research Organisation · PSUR · PSURs · Pharmacoeconomics, Health · Pharmacoeconomic studies · Pharmacoeconomics · Patient Monitoring · Monitoring Clinical Trials · Clinical Monitor · Marketing Authorisation · Medicinal Product Approval · Drug safety · Data management plan · Clinical development · Monitoring investigators · Non-interventional studies (NIS) · Patient recruitment · Phase IV studies · Investigator audit · Investigator qualification · Investigator selection